Odne Clean Receives FDA Clearance for Revolutionary Root Canal Disinfection

 

Today, Odne announced that it received clearance from the U.S. Food & Drug Administration for its endodontic debridement device, Odne Clean. The FDA regulates such devices as Class II medical devices, which are subject to premarket notification via the 510(k) pathway.

Odne Clean—with its 190 µm tip, the thinnest dental fluid-delivery tip on the market.

Odne Clean offers a novel approach to root canal disinfection, simplifying and accelerating the process. It creates a hydrodynamic cavitation cloud inside the root canal using only saline solution (sodium chloride) as the main irrigation medium. The cavitation jet removes debris inside the canals and tubules and increases the effectiveness of the final disinfection rinse with NaOCl. Odne Clean has the potential to reduce the risk of adverse events caused by harsh chemical disinfectants commonly used during root canal disinfection. With its 190 µm tip—the thinnest dental fluid-delivery tip on the market—Odne Clean supports minimally invasive root canal treatments, enabling endodontists and dentists to preserve as much tooth structure as possible. Initial clinical study results indicate that Odne Clean results in less postoperative pain compared to other techniques.

Odne’s Chief Operating Officer and co-founder, Mark Bispinghoff, commented, “With the clearance of Odne Clean, we now have U.S. market approval for our complete product portfolio for Root Canal Preservation (RPT). We are very proud of our team for going the extra mile and would like to thank our partners for their efficient collaboration in performing the extensive testing the FDA requires.”

In 2023, Odne received FDA clearance for Odne Fill, its innovative root canal obturation technique. Odne Fill is the first light-curing root canal filler that instantly photo-cures upon applying Odne Cure, a high-precision laser curing light. Together, these three Odne products represent a game-changing technology platform for minimally invasive Root Preservation Therapy (RPT), allowing endodontists and dentists to accelerate treatment and increase patient comfort.

“We are thrilled to now integrate Odne Clean into our Priority Access Program and make it available to our U.S. customer base,” said Andreas Schmocker, CEO and co-founder. “Our goal with the program is to continue to build strong clinical evidence, and, together with our clinicians, we will transform endodontics with a passion for innovation, scientific advancement, and clinical excellence.”

Odne recently initiated its Priority Access Program for innovative Root Preservation Therapy (RPT) at the AAE annual meeting in Los Angeles. The PAP will form the core of Odne’s scientific and clinical community, transforming endodontics. One initiative of the PAP is to establish a clinical case registry, collecting further knowledge on the clinical use of Odne’s devices for root canal treatment. Participating endodontists get the privilege of being among the first users of Odne’s devices and provide valuable user-related and scientific feedback.

1 Internal pre-clinical and clinical data on file.

About Odne

Odne AG (formerly Lumendo AG) has its roots in a groundbreaking collaboration between two renowned Swiss institutions: the Swiss Federal Institutes of Technology in Lausanne and Zürich (EPFL & ETH Zürich). Founded in 2018, Odne’s journey began by licensing cutting-edge technology assets from these esteemed institutes.

Odne is committed to pioneering the future of endodontics through advanced technology and innovative solutions. Endodontics, the field of dental medicine that deals with root canal treatments, has been marred by complexity and unpredictability. Odne is on a mission to change that.

Root canal treatments have long posed challenges for dentists, with traditionally low success rates ranging from 46% to 91%. With over 60 million annual treatments worldwide, these failures result in significant healthcare costs. Odne’s technology platform seeks to address these issues by offering treatment options for both dentists and their patients. Odne’s medical device portfolio, launched in the U.S. in April 2024, tackles problems such as the debridement and obturation of complex root canal morphologies. Recently, Odne Inc, USA, was founded to support the U.S. launch.

Odne is backed by venture capital funds focusing on healthcare and dental sectors. These include Revere Partners (NY), an independent venture fund providing capital for cutting-edge innovations in oral and systemic health, and NV Capital (LIE), a family-owned venture capital boutique that led the Series A financing. Alongside the lead investors, other renowned funds, such as Dental Innovation Alliance (DIA), Plug&Play, Hatcher, Züricher Kantonalbank, as well as various family offices and angel investors, are supporting Odne’s U.S. market launch.

Odne’s technology platform for Root Preservation Therapy (RPT) includes the first hydrodynamic cavitation device using saline as the main debridement medium and the first all-in-one, light-cured filling material.

Disclaimer: Odne Fill, Odne Cure, and Odne Clean are cleared for use in the U.S.A. only.

For more information, visit odne.co.